Tue.Apr 02, 2024

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FDA Clears First Digital Therapeutic to Treat Major Depressive Disorder

Drug Topics

Rejoyn from Otsuka Pharmaceutical and Click Therapeutics is a 6-week program that helps enhance cognitive control of emotions through brief therapy lessons and training exercises.

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STAT+: FDA clears digital stethoscope company’s AI algorithm for heart failure

STAT

An AI algorithm to detect heart failure, embedded in a digital stethoscope, earned clearance from the Food and Drug Administration on Tuesday. The goal is to help primary care doctors more easily identify the often-hidden condition. The stethoscope is the result of a collaboration between Mayo Clinic researchers, who built the algorithm, and the startup Eko Health, which built the hardware.

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Costco teams up with Sesame to offer weight loss program to members, including GLP-1 drugs

Fierce Healthcare

Big-box retailer Costco is expanding its reach into healthcare services with a new weight loss program for members. | Big-box retailer Costco is expanding its reach into healthcare services with a new weight loss program for members.

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STAT+: Watch: Medicare billing forms are running out of space for growing health care prices

STAT

WASHINGTON — Health care costs are getting so high that prices are literally running off of the page. Medicare on a couple of occasions recently has had to deal with billing forms that don’t provide adequate space for prices. CMS last month said it was adding two digits to the Medicare claims processing system for hospital and doctor office charges, called the Fiscal Intermediary Shared System, so that it can now accommodate prices just a penny shy of $100 million.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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Brepocitinib Shows Positive Results For Treatment of Non-Infectious Uveitis in Phase 2 Study

Drug Topics

Priovant Therapeutics said that it intends to initiate a phase 3 program of brepocitinib in the second half of this year.

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Pager Health's 3 new AI tools for payers could eliminate administrative costs

Fierce Healthcare

Virtual care navigation platform Pager Health has built three new enterprise tools using Google Cloud generative AI technology to better support its payer partners. | Pager Health revealed three new tools for payers powered by Google on Wednesday. The shift toward automating administrative tasks with AI represents a shift in how healthcare is conducted.

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Kaiser Permanente's Risant Health completes Geisinger Health acquisition

Fierce Healthcare

Kaiser Permanente’s Risant Health has closed its acquisition of Geisinger Health, notching the first step on its ambitious plan to form a multisystem, multiregional value-based care organization.

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Ending the silence: Why the menopause matters in the workplace

pharmaphorum

Discover the importance of addressing menopause in the workplace and the benefits of hormone replacement therapy (HRT) through this insightful and informative article on breaking the stigma.

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STAT+: Verve Therapeutics ‘pauses’ tests of its gene editor for heart disease and prioritizes a backup treatment

STAT

Verve Therapeutics said Tuesday that it is pausing testing of its closely watched gene-editing treatment for high cholesterol after a patient receiving the drug experienced elevated liver enzymes and low platelet levels. The news represents a setback for an ambitious project to not only bring forward one of the first gene-editing treatments in humans, but to also do so not for a rare condition but for the leading killer in the developed world.

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CMS finalizes network adequacy standards, expands dental benefits for ACA exchange

Fierce Healthcare

States now can add routine adult dental services as an essential health benefit, the Centers for Medicare & Medicaid Services announced in its 2025 Notice of Benefit and Payment Parameters fina | In its annual Notice of Benefit and Payment Parameters final rule, CMS prioritized dental and prescription drug benefits, network adequacy standardization and extended special enrollment periods.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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AstraZeneca Caps Inhaled Respiratory Portfolio at $35 For Eligible Patients With Asthma, COPD

Pharmacy Times

The Asthma and Allergy Foundation of America applauded the efforts by AstraZeneca, saying accessibility and affordability can help reduce racial disparities in asthma.

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STAT+: Roivant autoimmune drug succeeds in eye condition; company to buy back $1.5 billion in stock

STAT

A drug being developed by a Roivant subsidiary for a range of autoimmune conditions succeeded in a mid-stage trial in an eye disease that can ultimately lead to blindness, Roivant said Tuesday. Roivant, which has been flush with cash since selling a drug candidate to Roche last year for $7.1 billion, also announced Tuesday it was launching a $1.5-billion stock buyback initiative.

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Acorda inks $185M asset sale to Merz, files for bankruptcy after years of disappointing sales

Fierce Pharma

After years of struggling with hurdles such as generic competition and significantly lower-than-expected sales of its top meds, Acorda Therapeutics is hanging up the gloves with a $185 million deal | Merz Therapeutics, in a "stalking horse bid," agreed to pick up Acorda's Parkinson's disease med Inbrija and multiple sclerosis drug Amprya ahead of a court auction.

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FDA Tells Congress What It Wants, What it Really Really Wants (it really really really wants a zigazig-ah)

The FDA Law Blog

By Sara W. Koblitz — Every year, federal agencies submit a budget request to Congress to fund various agency initiatives, and every year FDA includes a list of legislative proposals that it would like to see come out of Congress. This year is no different , and in fact some of the requests on this year’s list are repeat offenders from last year’s. And though FDA may not have gotten everything that it wanted last year, reviewing and reflecting on these lists of legislative proposals provides im

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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‘Cliff’ Countdown: Balancing Internal and External Growth

Pharmaceutical Commerce

In this Pharmaceutical Commerce video interview, Joerg Tritschler, a partner in Simon-Kucher’s life sciences division, explores the two major strategies big pharma companies are employing amid current macro challenges and efforts to offset looming patent losses to blockbuster brands.

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Securing the future: Innovating pharmaceutical supply chain for resilience and safety

pharmaphorum

Explore the innovative use of artificial intelligence (AI) and machine learning (ML) in securing the pharmaceutical supply chain for resilience and safety. Learn how cutting-edge technology is shaping the future of pharmaceutical logistics.

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EP monographs allow rFC for water testing

European Pharmaceutical Review

Revised versions of two widely used European Pharmacopoeia (EP) monographs now allow the use of recombinant factor C (rFC) for testing of pharmaceutical waters. The revised monographs – Water for injections (0169) and Purified water (0008) – mean that users can select the rFC test described in Ph. Eur. 2.6.32 directly when testing pharmaceutical waters.

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The future of AI: Machine learning working together with scientific expertise

pharmaphorum

In a new episode of the pharmaphorum podcast recorded live on site at WIRED Health in London in March, web editor Nicole Raleigh spoke with Elise de Reus, co-founder of Cradle, the generative AI platform that helps scientists to design and program proteins.

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Endotoxin testing: the international regulatory landscape

European Pharmaceutical Review

Animal welfare is a crucial consideration in the adoption of alternative methods like recombinant Factor C (rFC) and recombinant Cascade Reagents (rCR) for bacterial endotoxin testing (BET). These methods aim to impede animal suffering by reducing dependence on horseshoe crab blood. At Roche, we see it as our ethical and environmental responsibility to support the use of alternative methods that prioritise animal welfare while ensuring the safety of our patients and the quality of our products.

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Ipsen licenses Sutro ADC in $900m deal

pharmaphorum

Ipsen has expanded its oncology pipeline by licensing rights to an antibody-drug conjugate (ADC) for solid tumours from Sutro Biopharma, its first drug in the category. The deal, which has a top-end value of $900 million including $90 million in near-term payments, focuses on STRO-003, a preclinical-stage ADC targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1).

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Lonza appoints new Chief Executive

European Pharmaceutical Review

Wolfgang Wienand has been chosen to succeed Albert Baehny as the CEO of Lonza. Wienand will join the contract development and manufacturing organisation (CDMO) in the summer of 2024. He has been CEO of the Swiss CDMO Siegfried Holding AG since 2019. Baehny has held his Chief Executive Officer ad interim role since October 2023 and will support Wienand through the transition period.

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STAT+: The biotech scoreboard for the second quarter: 32 stock-moving events to watch

STAT

Here is STAT’s biotech scoreboard, our regular ledger of stock-moving biotech events, for the second quarter and middle of the year: Obesity catalysts, first. Danish drugmaker Zealand Pharma — yes, there’s another Danish drug maker in obesity — is developing a long-acting amylin analog called petrelintide. The experimental medicine has garnered attention for its potential to show incretin-like weight loss with muscle preservation, and a tolerable side-effect profile.

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As Polypharmacy Grows, Pharmacists Play Essential Role in Medication Education

Pharmacy Times

By implementing easier systems of education for patients, the consequences of polypharmacy could potentially decrease.

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Acorda filed for bankruptcy, and Merz is eyeing its assets

pharmaphorum

Acorda Therapeutics has filed for bankruptcy protection, hoping to keep operating while it tries to arrange the sale of its main assets to a US subsidiary of Germany’s Merz. The announcement made last night US time sparked a run on Acorda's shares, down almost 62% at the time of writing. The news emerged shortly after Acorda cancelled its fourth-quarter results conference call, which was scheduled to take place yesterday.

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FDA Accepts BLA for Dato-DXd to Treat Unresectable, Metastatic HR-Positive, HER2-Negative Breast Cancer

Pharmacy Times

The decision follows phase 3 trial results that demonstrated improved progression-free survival and confirmed the safety of Dato-DXd in patients with breast cancer.

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AZ, Daiichi Sankyo file Dato-DXd for second indication

pharmaphorum

AstraZeneca and Daiichi Sankyo file for approval of datopotamab deruxtecan (Dato-DXd) for second indication in breast cancer.

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HCA Healthcare rolls out in-EHR referrals to Talkiatry's telepsychiatrists

Fierce Healthcare

Primary and urgent care providers within HCA Healthcare’s network now have the option to refer their patients to Talkiatry’s full-time psychiatrists from within their electronic health record thank | The integration, which is live across the "vast majority" of HCA's systems, allows primary and urgent care physicians to quickly refer a patient for a virtual psychiatric visit.

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Teva, Viatris revive patent challenge on J&J's long-acting schizophrenia blockbuster Invega Sustenna

Fierce Pharma

After incurring a loss in New Jersey federal court in 2021, Teva and Viatris have successfully resurrected challenges to the last remaining U.S. | After incurring a loss in New Jersey federal court in 2021, Teva and Viatris have successfully resurrected challenges to the last remaining U.S. patent on a lucrative Johnson & Johnson schizophrenia drug.

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Adagrasib Meets Primary Endpoint Among Individuals with KRAS G12C-Mutated Locally Advanced or Metastatic NSCLC

Pharmacy Times

The positive results in both progression-free survival and overall response rate were endorsed in a confirmatory study.

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Bora Pharmaceuticals completes Upsher-Smith acquisition, expanding North American footprint

Outsourcing Pharma

Bora Pharmaceuticals Co., Ltd. yesterday (April 1) finalized the acquisition of Upsher-Smith Laboratories, Inc., a leading generics manufacturer based in Minnesota, U.S., from its previous owners, Sawai Group Holdings and Sumitomo Corporation of Americas.

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Advise Patients About OTC Options for Treating Motion Sickness

Pharmacy Times

Many cases of motion sickness can be managed safely with available OTC products.

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Data integration - has an influx of solution providers led to a litany of false starts and wasted effort?

Outsourcing Pharma

OSP was lucky enough to talk to David Menzies (pictured), executive director, technology solutions at ICON to find out how he thinks the pharma industry needs to overcome the real-world data challenges.

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Senator probes private equity, physician staffing firms for emergency care cost cutting

Fierce Healthcare

Yet another congressional inquiry is seeking information on private equity’s role in care delivery, this time on whether their investments in emergency physician staffing firms are leaving hospital | Staffing reductions and other cost reduction moves in the emergency department can have "homeland security implications," Sen. Gary Peters, D-Michigan, wrote in inquiry letters to three private equity firms and the distressed physician staffing companies they control.

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The Power of Patient Adherence Tools to Improve the Patient Journey

Pharmaceutical Commerce

Why manufacturers should leverage technology to address low adherence rates.

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